SANDARE HEMOGLOBIN CONTROLS

Mixture, Hematology Quality Control

SANDARE CHEMICAL CO., INC.

The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Hemoglobin Controls.

Pre-market Notification Details

Device IDK792209
510k NumberK792209
Device Name:SANDARE HEMOGLOBIN CONTROLS
ClassificationMixture, Hematology Quality Control
Applicant SANDARE CHEMICAL CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-02
Decision Date1979-12-04

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